- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07636239
Eating Behavior, Nutritional Status and Appetite Hormones After Bariatric Surgery (BCKYL-YDB)
Evaluation of Changes in Postoperative Eating Behavior Attitudes, Nutritional Status, and Some Hormonal Parameters Regulating Appetite in Surgical Weight Management
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
This observational study will be conducted at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, under the supervision of Assoc. Prof. Dogukan Durak. Forty volunteer participants who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month and meet the inclusion and exclusion criteria will be enrolled after signing an informed consent form.
Assessments will be performed at two time points: at baseline (shortly after surgery) and at 6-month follow-up.
Anthropometric Measurements: Body weight, height, waist and hip circumference will be measured. BMI and waist-to-hip ratio will be calculated accordingly. Waist circumference will be evaluated according to WHO criteria.
Dietary Assessment: A 3-day dietary intake record will be collected from each participant at both time points. Food portion sizes will be estimated using the "Food and Nutrient Photo Catalog." Energy and macronutrient intake will be analyzed using BeBIS 8.2 software and evaluated according to the Turkish Dietary Guidelines 2022 (TUBER 2022).
Eating Behavior Assessment: The Adult Eating Behavior Scale (developed by Celik et al.) will be administered at both time points. The scale consists of 18 items and 5 subscales, scored between 0-100. Higher scores indicate more positive attitudes toward eating behavior.
Biochemical and Hormonal Parameters: After 12-hour fasting, the following biochemical parameters will be obtained from patient files: fasting blood glucose (FBG), total cholesterol (TC), triglycerides (TG), high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, very low-density lipoprotein (VLDL) cholesterol, and insulin. Routine biochemical parameters and lipid profile will be analyzed spectrophotometrically using the Advia Chemistry 2400 device, while insulin will be measured by chemiluminescence using the Advia XPT device. Additionally, appetite-regulating hormones including ghrelin, glucagon-like peptide-1 (GLP-1), and peptide YY (PYY) will be analyzed from residual blood samples stored at -20°C by Teknogen Bioengineering Laboratory using the ELISA method with an automated microplate reader (Biotek TS800) and RelAssay Diagnostics commercial kits (Ankara, Turkey).
All data will be compared between baseline and 6-month follow-up using appropriate statistical methods.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Numero di telefono: +903246253300
- Email: dytozlemozpak@hotmail.com
Backup dei contatti dello studio
- Nome: Doğukan DURAK, Assoc. Prof.
- Numero di telefono: +905327243733
- Email: dogukandurak404@hotmail.com
Luoghi di studio
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Bursa
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Bursa, Bursa, Turchia (Türkiye), 16130
- Bursa Yıldırım Doruk Hastanesi, General Surgery Clinic
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Contatto:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
- Numero di telefono: +903246253300
- Email: dytozlemozpak@hotmail.com
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Contatto:
- Doğukan DURAK, Assoc. Prof.
- Numero di telefono: +905327243733
- Email: dogukandurak404@hotmail.com
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Investigatore principale:
- Özlem ÖZPAK AKKUŞ, Assoc. Prof.
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Sub-investigatore:
- Doğukan Durak, Assoc. Prof.
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Sub-investigatore:
- Seher ŞEN, Asst. Prof.
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Sub-investigatore:
- Tuğçe Nur DOĞANAY YILDIRIM, MSc, RD
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
Inclusion Criteria:
- Having undergone Laparoscopic Sleeve Gastrectomy (LSG) within the last month
- Aged between 18-50 years
- Signing the informed consent form
- Having a Body Mass Index (BMI) of 40 kg/m2 or between 35-40 kg/m2 with obesity-related comorbidities
- No diagnosis of depression
- No eating behavior disorder
- No psychiatric disorder
Exclusion Criteria:
- Not having undergone Laparoscopic Sleeve Gastrectomy (LSG) or not planning to undergo bariatric surgery
- Not being in the age range of 18-50 years
- Not signing the informed consent form
- Having a Body Mass Index (BMI) greater than 40 kg/m2 or less than 35 kg/m2 without obesity-related comorbidities
- Having a diagnosis of depression
- Having an eating behavior disorder
- Having a psychiatric disorder
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
|---|---|
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LSG Patients
Individuals who underwent Laparoscopic Sleeve Gastrectomy (LSG) within the last month at Bursa Yıldırım Doruk Hospital, General Surgery Clinic, and meet the inclusion and exclusion criteria.
Participants will be assessed at baseline (shortly after surgery) and at 6-month follow-up.
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Anthropometric measurements (body weight, height, waist and hip circumference, BMI, waist-to-hip ratio), 3-day dietary intake records, Adult Eating Behavior Scale, and biochemical and hormonal parameters (fasting blood glucose, lipid profile, insulin, ghrelin, GLP-1, PYY) will be assessed at baseline and at 6-month follow-up.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Serum Ghrelin Concentration (pg/mL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in serum ghrelin levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Serum GLP-1 Concentration (pmol/L)
Lasso di tempo: Baseline and 6 months after surgery
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Change in serum glucagon-like peptide-1 (GLP-1) levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Serum PYY Concentration (pg/mL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in serum peptide YY (PYY) levels between baseline and 6-month follow-up, assessed by ELISA method.
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Baseline and 6 months after surgery
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Change in Adult Eating Behavior Scale Total Score (0-100)
Lasso di tempo: Baseline and 6 months after surgery
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Change in Adult Eating Behavior Scale total score between baseline and 6-month follow-up.
Scale is scored between 0-100; higher scores indicate more positive eating behavior attitudes.
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Baseline and 6 months after surgery
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Change in Daily Energy Intake (kcal/day)
Lasso di tempo: Baseline and 6 months after surgery
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Change in daily energy intake assessed by 3-day dietary intake records at baseline and 6-month follow-up.
Food portions will be estimated using the Food and Nutrient Photo Catalog.
Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
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Baseline and 6 months after surgery
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Change in Daily Protein Intake (g/day)
Lasso di tempo: Baseline and 6 months after surgery
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Change in daily protein intake assessed by 3-day dietary intake records at baseline and 6-month follow-up.
Food portions will be estimated using the Food and Nutrient Photo Catalog.
Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022
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Baseline and 6 months after surgery
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Change in Daily Carbohydrate Intake (g/day)
Lasso di tempo: Baseline and 6 months after surgery
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Change in daily carbohydrate intake assessed by 3-day dietary intake records at baseline and 6-month follow-up.
Food portions will be estimated using the Food and Nutrient Photo Catalog.
Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
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Baseline and 6 months after surgery
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Change in Daily Fat Intake (g/day)
Lasso di tempo: Baseline and 6 months after surgery
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Change in daily fat intake assessed by 3-day dietary intake records at baseline and 6-month follow-up.
Food portions will be estimated using the Food and Nutrient Photo Catalog.
Data will be analyzed using BeBIS 8.2 software and evaluated according to Turkish Dietary Guidelines 2022.
|
Baseline and 6 months after surgery
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Body Weight (kg)
Lasso di tempo: Baseline and 6 months after surgery
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Change in body weight between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Body Mass Index (kg/m²)
Lasso di tempo: Baseline and 6 months after surgery
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Change in BMI between baseline and 6-month follow-up.
Weight and height will be combined to report BMI in kg/m².
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Baseline and 6 months after surgery
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Change in Waist Circumference (cm)
Lasso di tempo: Baseline and 6 months after surgery
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Change in waist circumference between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Hip Circumference (cm)
Lasso di tempo: Baseline and 6 months after surgery
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Change in hip circumference between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Waist-to-Hip Ratio
Lasso di tempo: Baseline and 6 months after surgery
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Change in waist-to-hip ratio between baseline and 6-month follow-up.
Waist and hip circumference measurements will be combined to calculate the waist-to-hip ratio.
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Baseline and 6 months after surgery
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Change in Fasting Blood Glucose Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in fasting blood glucose levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Total Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in total cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Triglyceride Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in triglyceride levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in HDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in high-density lipoprotein (HDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in LDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in low-density lipoprotein (LDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in VLDL Cholesterol Concentration (mg/dL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in very low-density lipoprotein (VLDL) cholesterol levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Change in Fasting Insulin Concentration (µIU/mL)
Lasso di tempo: Baseline and 6 months after surgery
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Change in fasting insulin levels between baseline and 6-month follow-up.
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Baseline and 6 months after surgery
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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Özlem ÖZPAK AKKUŞ, Assoc. Prof., Toros University
Pubblicazioni e link utili
Pubblicazioni generali
- Physical status: the use and interpretation of anthropometry. Report of a WHO Expert Committee. World Health Organ Tech Rep Ser. 1995;854:1-452.
- Sherf Dagan S, Goldenshluger A, Globus I, Schweiger C, Kessler Y, Kowen Sandbank G, Ben-Porat T, Sinai T. Nutritional Recommendations for Adult Bariatric Surgery Patients: Clinical Practice. Adv Nutr. 2017 Mar 15;8(2):382-394. doi: 10.3945/an.116.014258. Print 2017 Mar.
- Celik E, Karabulut E, Bilgic P. Bariatrik Cerrahi Hastalarinda Beslenme ve Davranis Tutumu Olcegi. Bes Diy Derg. 2017;45(2):107-15.
- Pekcan G, Sanlier N, Bas M, Acar Tek N, Gokmen Ozel H. Turkiye Beslenme Rehberi (TUBER) 2022. Ankara: Hazar Reklamcilik; 2022.
- Beslenme Bilgi Sistemleri Paket Programi (BeBIS 8.2). Istanbul: Software NDB; 2015.
- Merdol TK. Toplu Beslenme Yapilan Kurumlar icin Standard Yemek Tarifleri. Hatipoglu Yayinlari; 2003.
- Rakicioglu N, Tek NA, Ayaz A, Pekcan G. Yemek ve Besin Fotograf Katalogu Olcu ve Miktarlar. Nadir Kitap; 2012.
- Pekcan G. Beslenme Durumunun Saptanmasi. Diyet El Kitabi. Ankara: Hatipoglu Yayinevi; 2013:67-142.
- Baltaci G. Obezite ve egzersiz. Saglik Bakanligi Yayinlari, Ankara; 2008.
- World Health Organization. Prevention and management of the global epidemic of obesity. Report of the WHO Consultation on Obesity. Geneva: WHO; 1997.
- Rigamonti AE, Bini S, Rocco MC, Giardini V, Massimini D, Crippa MG, Saluzzi A, Casati M, Marazzi N, Perotti M, Cimino V, Grassi G, Sartorio A, Pincelli AI. Post-prandial anorexigenic gut peptide, appetite and glucometabolic responses at different eating rates in obese patients undergoing laparoscopic sleeve gastrectomy. Endocrine. 2017 Jan;55(1):113-123. doi: 10.1007/s12020-016-0933-6. Epub 2016 Mar 29.
- Devlin MJ, Goldfein JA, Flancbaum L, Bessler M, Eisenstadt R. Surgical management of obese patients with eating disorders: a survey of current practice. Obes Surg. 2004 Oct;14(9):1252-7. doi: 10.1381/0960892042386940.
- Brown W, Dixon JB, Brien PO. Management of obesity--the role of surgery. Aust Fam Physician. 2006 Aug;35(8):584-6.
- Katsanos CS, Madura JA 2nd, Roust LR. Essential amino acid ingestion as an efficient nutritional strategy for the preservation of muscle mass following gastric bypass surgery. Nutrition. 2016 Jan;32(1):9-13. doi: 10.1016/j.nut.2015.07.005. Epub 2015 Aug 5.
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
- Disturbi della nutrizione
- Ipernutrizione
- Peso corporeo
- Cambiamenti di peso corporeo
- Sovrappeso
- Condizioni patologiche, segni e sintomi
- Comportamento
- Malattie nutrizionali e metaboliche
- Segni e sintomi
- Comportamento, animale
- Obesità
- Perdita di peso
- Comportamento alimentare
- Qualità, accesso e valutazione dell'assistenza sanitaria
- Tecniche investigative
- Metodi epidemiologici
- Raccolta dei dati
- Meccanismi di valutazione dell'assistenza sanitaria
- Qualità dell'assistenza sanitaria
- Sanità pubblica
- Ambiente e salute pubblica
- Misurazioni epidemiologiche
- Valutazione nutrizionale
Altri numeri di identificazione dello studio
- BCKLY-YDB-2026
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Descrizione del piano IPD
Informazioni su farmaci e dispositivi, documenti di studio
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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